Comparison of the Effect of Traditional Method and Eras Protocol in Obesity Surgery

NCT05790317 | Completed

• 1 other identifier: Bau-bahcesehir university
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to compare the effectiveness of care based on the "Accelerated Recovery After Surgery (ERAS) Protocol" and the traditional method in bariatric surgery and demonstrate the difference the two methods based on evidence.

Conditions

Obesity, Morbid; Bariatric Surgery Candidate; Obesity Adult Onset; Obesity Associated Disorder; Diabetes; Nausea; Ache; Pain, Postoperative; Postoperative Nausea; Postoperative Nausea and Vomiting; Post Procedural Discharge; ERAS; DVT

Keywords

DVT; BKÖİ; DSÖ; ASA; BKI; BPD; CVI; DMAH; ERAS; FTS; IASMEN; MBT; LSG

Outcome Measures

Primary Outcomes (2)

• Presence and level of postoperative pain

  In the sample calculation of the research; To measure the significant differences between independent groups, a minimum of 128 samples is required (64 for each group) in order to determine 80% statistical power and α = 0.05 significance and d = 0.50 effect size in the t-test to be performed. In order to evaluate the effect of the post-operative accelerated recovery (ERAS) protocol on the patient recovery process, 128 patients who applied to the hospital for bariatric surgery between April and June 2022 were included in the study. 64 patients were divided into groups as the ERAS Protocol group and 64 patients as the control group. Postoperative pain status was evaluated with the McGill Pain Questionnaire (SF-MPQ). In determining the severity of pain, the McGill Pain Scale Numerical Evaluation was evaluated as 0-10 points, 0 no pain, 10 unbearable pain. A score of 4 or less for patients meant less pain.

  3 days

• Presence of post-operative nausea, vomiting and retching

  Postoperative nausea, vomiting and retching were evaluated with the "Rhodes Nausea-Vomiting Rectal Index". According to the sub-dimensions of the scale, each of the symptoms of nausea, vomiting and retching was scored in the range of 0-12 points. 0 meant the least distress - 12 meant the most distress.

  3 days

Study Arms (2)

Surgical Procedure with ERAS Protocol

EXPERIMENTAL

ERAS Maintenance Protocol The basic philosophy of the ERAS Protocol is to reduce metabolic stress due to surgical trauma, and to return to normal activity as soon as possible by supporting the normalization of functions in a short time. ERAS protocols are a protocol consisting of a total of 24 items covering the perioperative period of a patient, which starts in the outpatient clinic in the preoperative period and ends at home with discharge. includes applications. Elements of this preparation and treatment method, which is different from the traditional, were applied to our patients in this group before (11), during the operation (6) and after the operation (7). In the study, the data were collected with the personal introduction form introducing the characteristics of the patients, the Rhodes Nausea-Vomiting and Regurgitation Index (WPI), the Mcgill Pain Scale and the Postoperative Evaluation Form created within the scope of the ERAS Care Protocol.

Procedure: Surgical Procedure with ERAS Protocol

Surgery Procedure with the traditional method

NO INTERVENTION

ItThe group that underwent surgery with the traditional method is the control group. The surgical procedure preparation procedure in the institution where the study was conducted was not exceeded. The data in the control group were collected with the patient information form, the Postoperative Evaluation Form to evaluate the symptoms after the surgical intervention, the McGill Pain Scale Short Form, the Rhodes Nausea-Vomiting Regurgitation Index.

Interventions

Surgical Procedure with ERAS Protocol PROCEDURE

It covers the period before, during and after the surgery.

Also known as: Fast Track Surgery

Surgical Procedure with ERAS Protocol

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age who underwent bariatric surgery
• Open to communication and collaborative,
• Patients who volunteered to take part in the study

You may not qualify if:

• Patients with major visual, hearing and speech impairments
• Patients who want to withdraw from the study at any stage of the study

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Bahcesehir university

Istanbul, Besiktas, 34349, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, Morbid; Diabetes Mellitus; Nausea; Pain; Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms, Digestive; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Vomiting

Study Officials

• Eylül Tülay Aykul, master

  Bahçeşehir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: training nurse

Study Record Dates

• First Submitted: December 18, 2022
• First Posted: March 30, 2023
• Study Start: February 14, 2022
• Primary Completion: July 31, 2022
• Study Completion: February 10, 2023
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

TU (1)